FDA (Drugs) recall action 87038
The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Cipla is recalling 284,610 packets of Esomeprazole Magnesium delayed-release oral suspension because the excipient Crospovidone is contaminated with theophylline.
Cipla is recalling Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg due to cross-contamination with theophylline in the excipient Crospovidone.
Cipla is recalling specific lots of Esomeprazole Magnesium delayed-release oral suspension because the excipient Crospovidone is contaminated with theophylline.